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Use Of Valproid Acid To Treat Tropical Spastic Paraparesis/HTLV-1-Associated Myelopathy (TSP/HAM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00681980
First Posted: May 21, 2008
Last Update Posted: December 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jorge Casseb, University of Sao Paulo
  Purpose
Is the valproic acid efficacy to treat TSP/HAM

Condition Intervention Phase
Paraparesis Spastic Tropical Drug: Valproic acid Drug: costicosteroids Drug: valproid acid plus corticosteroids Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Of Valproic Acid To Treat TSP/HAM Patients In Sao Paulo, Brazil

Resource links provided by NLM:


Further study details as provided by Jorge Casseb, University of Sao Paulo:

Primary Outcome Measures:
  • Neurological sacles [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 2009 ]

Enrollment: 60
Study Start Date: February 2008
Study Completion Date: December 2015
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A, 2, III
Patients with side effects to corticosteroids
Drug: Valproic acid
15 mg/kg/day
Experimental: B
patient with corticosteroids
Drug: costicosteroids
metypredsolone 1 g/day
Experimental: 3
Valproic acid and corticosteroids
Drug: valproid acid plus corticosteroids
valporid acid 15 mg/kg/day plus corticosteroids 1 g/patient

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HTLV-1; TSP/HAM fulfill criteria

Exclusion Criteria:

  • Age <18 years
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681980


Locations
Brazil
Institute of Tropical Medicine at Sao Paulo University
Sao Paulo, SP, Brazil, 0543903
Sponsors and Collaborators
University of Sao Paulo
  More Information

Additional Information:
Responsible Party: Jorge Casseb, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00681980     History of Changes
Other Study ID Numbers: 278
First Submitted: May 19, 2008
First Posted: May 21, 2008
Last Update Posted: December 3, 2015
Last Verified: December 2015

Keywords provided by Jorge Casseb, University of Sao Paulo:
TSP/HAM, HTLV-1, treatment

Additional relevant MeSH terms:
Muscle Spasticity
Paraparesis
Paraparesis, Tropical Spastic
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Paresis
HTLV-I Infections
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases
Valproic Acid
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants